Telmisartan Tablet
FDA Recall NDC 62332-088
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Telmisartan (NDC 62332-088). A significant event, classified as Class I, was initiated on Mar 17, 2021 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "Labeling: Label-mixup"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Labeling: Label-mixup
Mar 17, 2021
Apr 14, 2021
12288 bottles
Recall Profile & Regulatory Data
Event ID
87533
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 05, 2022
Product Description
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
Batch or Lot Expiration Information
Lot# : 1905005661, Exp March 2022
Affected Packages Involved in this Recall
62332-087-10Product
62332-087-30Product
62332-087-91Product
62332-088-10Product
62332-088-30Product
62332-088-91Product
62332-089-10Product
62332-089-30Product
62332-089-91Product
1905005661Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
